Status:
ACTIVE_NOT_RECRUITING
Prepectoral and Subpectoral Implant-based Breast Reconstruction
Lead Sponsor:
Fudan University
Conditions:
Breast Carcinoma
Breast Reconstruction
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Breast cancer is one of the main malignant tumors threatening women's lives. In recent years, the increasing demand for reconstruction of breast cancer patients in China has made the proportion of bre...
Eligibility Criteria
Inclusion
- More than 18 years old
- Female
- Preoperative pathology confirming invasive breast carcinoma or ductal carcinoma in situ
- Clinical T1 and T2 (Maximum tumor diameter ≤5 cm)
- Clinical ALN negative (Clinical physical examination and ultrasound indicate axillary lymph node negative; Suspected abnormality of axillary lymph node, and fine needle aspiration negative)
- No clinical or imaging evidence of distant metastasis
- Patients to receive skin sparing mastectomy or nipple sparing mastectomy
- BMI \< 35
- Patients with no or mild mastoptosis
- Prosthesis to be implanted \<500 ml
- Be able and willing to sign the Informed Consent Form (ICF)
Exclusion
- Patients with the breast of moderate-severe mastoptosis, or requiring the use of Wise-pattern or other breast lift methods for subcutaneous mammary gland resection
- BMI\>=35
- Patients who have received symmetrical breast surgery on the unaffected side immediately or later
- Patients with locally advanced breast cancer to receive neoadjuvant therapy
- Patients currently participating in other clinical trials, which may have impact on the participation in this trial
- Neoadjuvant therapy has been completed, and there is clear indication of adjuvant radiotherapy after the operation
- Previous history of breast cancer (patients with ipsilateral recurrence after breast sparing surgery)
- Pregnancy breast-feeding women
- History of smoking
- Previous history of diabetes
Key Trial Info
Start Date :
May 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04688697
Start Date
May 12 2021
End Date
December 31 2025
Last Update
April 2 2025
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China